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Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome

Expanded access is currently available for this treatment.
Verified October 2008 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00765557
First received: September 30, 2008
Last updated: October 2, 2008
Last verified: October 2008
September 30, 2008
October 2, 2008
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Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome
Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome

We hypothesize fecal retention is the primary source of bladder dysfunction in some children with Urge Syndrome. Our specific aims are:

  1. To test this hypothesis through a prospective, randomized, double-blinded and placebo-controlled trial of laxatives for children diagnosed with US.
  2. To determine if a validated questionnaire of bowel activity administered to the family, and when appropriate, the patient, will identify those likely to benefit from laxative therapy for bladder dysfunction.
  3. To determine if the abdominal X-Ray of the kidneys, ureters and bladder (KUB) assessment of fecal loading corresponds to answers on the questionnaire regarding incidence of constipation, and/or response to laxative therapy for US.
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Expanded Access
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Urge Syndrome
Drug: Miralax
Every subject will be given one bottle of the laxative/placebo, and depending on the patient's weight, will be instructed to take 1-3 tsps (.75 gm/kg) of the medication daily.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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Inclusion Criteria:

  • Toilet-trained with a history of urinary tract infection; vesicoureteral reflux; urinary incontinence; daily frequency and urgency; and diurnal incontinence.

Exclusion Criteria:

  • Children who are below 4 years old as they may still not be toilet-trained; children with encopresis; children with anorectal malformations; and children with neurologic disorders.
Sexes Eligible for Study: All
4 Years to 21 Years   (Child, Adult)
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Contact: Warren T Snodgrass, M.D. 214-456-2483 Warren.Snodgrass@childrens.com
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NCT00765557
122004-038
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Warren T. Snodgrass, M.D., University of Texas Southwestern Medical School
University of Texas Southwestern Medical Center
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University of Texas Southwestern Medical Center
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP